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Sr Quality EngineerPenumbra, Inc. · Alameda, CA
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Penumbra, Inc.

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Sr Quality Engineer

🗓️ Posted 2026-08-06 Alameda, CA External Hybrid Manufacturing Transport Logistics
💰 Salary Not shared 📊 Market 8,500 CAD–12,500 CAD/mo

About the Company

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant. No. 5 on the Greater Bay Area Manufacturers List, San Francisco Business Times, 2020 100 Fastest-Growing Companies, Fortune, 2019 Review our community guidelines for LinkedIn here: https://bit.ly/2Jmbw83. Medical Equipment Manufacturing Specialties: Neurointerventional devices, Stroke treatment, Vascular access, Thrombectomy systems, Interventional radiology, Medical device innovation

Responsibilities

  • ● General Summary
  • ● The Senior Quality Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Monitor design control and provide quality assurance support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.
  • ● Specific Duties and Responsibilities
  • ● Participate in the development and qualification activities for new and existing products.
  • ● Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes.
  • ● Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements.
  • ● Perform engineering work including one or more of the following:
  • ● Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
  • ● Develop and validate measurement methods
  • ● Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
  • ● Support developmental projects in the area of quality assurance
  • ● Analyze reports and returned products and recommend corrective and preventive action
  • ● Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
  • ● Participate in NCR or CAPA board as necessary
  • ● Assist in and perform QSR training.
  • ● Support activities during FDA inspections, FDB inspections, and notified body audits.
  • ● Participate in the development of standard operating procedures.
  • ● Prepare documentation for inspection/testing procedures.
  • ● Perform responsibilities required by the Quality System and other duties as assigned.
  • ● Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.